METHOD FOR PROGRAMMING AN IMPLANTABLE MEDICAL DEVICE

Abstract

A method for programming an implantable medical device for stimulating a human or animal heart with the help of a programming device. The method comprises the following steps: a) providing a first input parameter to the programming device, the first input parameter being indicative whether a first stimulation unit is to be used to stimulate the His bundle of a heart; b) if the first input parameter indicates that the first stimulation unit is to be used to stimulate the His bundle of the heart, supporting a user of the programming device to configure the implantable medical device for His bundle pacing by automatically proposing at least one stimulation parameter and an assigned stimulation parameter value specifically adapted for His bundle pacing; c) allowing programming of the implantable medical device by allowing setting the at least one stimulation parameter value.

Claims

1. Method for programming an implantable medical device for stimulating a human or animal heart with the help of a programming device, the implantable medical device comprising a first processor, a first memory unit, a first stimulation unit configured to stimulate a cardiac region of a human or animal heart, and a first detection unit configured to detect an electrical signal at the cardiac region of the same heart, the method comprising the following steps: a) providing a first input parameter to the programming device, the first input parameter being indicative whether the first stimulation unit is to be used to stimulate the His bundle of the heart; b) if the first input parameter indicates that the first stimulation unit is to be used to stimulate the His bundle of the heart, supporting a user of the programming device to configure the implantable medical device for His bundle pacing by automatically proposing at least one stimulation parameter and an assigned stimulation parameter value specifically adapted for His bundle pacing; and c) allowing programming of the implantable medical device by allowing setting the at least one stimulation parameter value.

2. Method according to claim 1, wherein a presence of a His bundle electrode is automatically detected, wherein a positively detected presence is used as the first input parameter.

3. Method according to claim 1, wherein a set of stimulation parameters and assigned stimulation parameter values specifically adapted for His bundle pacing is automatically proposed.

4. Method according to claim 1, wherein prior to step b) at least one second input parameter is provided, wherein the at least one stimulation parameter and the assigned stimulation parameter value are proposed in additional dependence on the at least one second input parameter, wherein the at least one second input parameter is chosen from the group consisting of an indication on a port of the implantable medical device to which a His bundle electrode is connected, an indication on a patient's cardiac disease to be treated with the implantable medical device, an indication on a type of the implantable medical device, an indication on a model of the implantable medical device, an indication on a number of ports of the implantable medical device, and an indication on a cardiac chamber into which a lead connected to a port of the implantable medical device is placed.

5. Method according to claim 4, wherein the information on a kind of the patient's cardiac disease to be treated with the implantable medical device is retrieved by the programming device from a database.

6. Method according to claim 4, wherein the patient's cardiac disease to be treated with the implantable medical device is chosen from the group consisting of bradycardia with permanent atrial fibrillation or flutter, paroxysmal or permanent high-degree atrio-ventricular block, heart failure with normal sinus rhythm, heart failure, heart failure with permanent atrial fibrillation or flutter, sick-sinus syndrome, brady-tachy syndrome, sick-sinus syndrome with chronotropic competence, dual node disease and permanent atrio-ventricular block, dual node disease and paroxysmal atrio-ventricular block, vasovagal syncope, symptomatic first-degree atrio-ventricular block, infrequent paroxysmal cardiac pauses.

7. Method according to claim 4, wherein the second input parameter is automatically determined and is chosen from the group consisting of an indication on a port of the implantable medical device to which a His bundle electrode is connected, an indication on a type of the implantable medical device, an indication on a model of the implantable medical device, an indication on a number of ports of the implantable medical device, and an indication on a cardiac chamber into which a lead connected to a port of the implantable medical device is placed.

8. Method according to claim 1, wherein it is made possible to change the stimulation parameter value assigned to the at least one stimulation parameter.

9. Method according to claim 8, wherein it is made possible to save a set of stimulation parameters and assigned stimulation parameter values, the set comprising at least one stimulation parameter value changed with respect to an original setting.

10. Method according to claim 8, wherein an automatic check is performed aiming at identifying a conflict between a changed stimulation parameter value and other stimulation parameter values of the same set of stimulation parameters.

11. Method according to claim 10, wherein an alert is created in case of an identified conflict.

12. Arrangement comprising an implantable medical device for stimulating a human or animal heart and a programming device, the implantable medical device comprising a first processor, a first memory unit, a first stimulation unit configured to stimulate a cardiac region of a human or animal heart, and a first detection unit configured to detect an electrical signal at the cardiac region of the same heart, the programming device comprising a second processor and a second memory unit, wherein the second memory unit comprises a computer-readable program that causes the second processor to perform the following steps when executed on the processor: a) obtaining a first input parameter, the first input parameter being indicative whether the first stimulation unit is to be used to stimulate the His bundle of the heart; b) if the first input parameter indicates that the first stimulation unit is to be used to stimulate the His bundle of the heart, supporting a user of the programming device to configure the implantable medical device for His bundle pacing by automatically proposing at least one stimulation parameter and an assigned stimulation parameter value specifically adapted for His bundle pacing; and c) allowing programming of the implantable medical device by allowing setting the at least one stimulation parameter value.

13. Arrangement according to claim 12, wherein the programming device comprises a display for displaying a graphical user interface.

14. Computer program product comprising computer-readable code that causes a processor to perform the following steps when executed on the processor: a) obtaining a first input parameter, the first input parameter being indicative whether a first stimulation unit of an implantable medical device is to be used to stimulate the His bundle of a heart; b) if the first input parameter indicates that the first stimulation unit is to be used to stimulate the His bundle of the heart, supporting a user of a programming device to configure the implantable medical device with the help of the programming device for His bundle pacing by automatically proposing at least one stimulation parameter and an assigned stimulation parameter value specifically adapted for His bundle pacing; and c) allowing programming of the implantable medical device by allowing setting the at least one stimulation parameter value.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Further details of aspects of the present invention will be described in the following making reference to exemplary embodiments and an accompanying FIGURE.

[0052] FIG. 1 shows an arrangement of a pacemaker and a programming device.

DETAILED DESCRIPTION

[0053] FIG. 1 shows an arrangement of a pacemaker 1 and programming device 2. The pacemaker 1 comprises a port 3 into which a His bundle electrode 4 is inserted. The His bundle electrode 4 comprises an electrode 5 at its distal end which is implanted at the His bundle 6 of a human heart 7.

[0054] The programming device 2 comprises a display 8 for enabling an interaction with a user of the programming device 2. The programming device 2 and the pacemaker 1 are operatively coupled to each other by a wireless radio communication 9. Due to this wireless radio communication 9, it is possible to program the pacemaker 1 with the help of the programming device 2. For carrying out such programming, the programming device 2 first requests an input whether a His bundle electrode is connected to the pacemaker 1. In the present embodiment, the His bundle electrode 4 is connected to the pacemaker 1 so that an according question is to be answered by “yes”. This can be done manually by confirming a corresponding prompt. Alternatively, the respective information can be automatically obtained by the programming device 2 from the implantable pacemaker 1.

[0055] Depending on further input parameters, such as the type of the pacemaker 1, the health status of the patient the heart 7 of which is to be stimulated by the pacemaker 1 and the port 3 into which the His bundle electrode 4 is plugged in, the programming device 2 proposes an appropriate therapy setting for stimulating the His bundle 6 of the human heart 7. Individual parameters of this therapy setting can be adjusted by a user, if desired. Afterwards, the choice of the optionally adjusted therapy setting is confirmed and transferred to the pacemaker 1 so that the pacemaker 1 will start operation or continue operation by using the transmitted therapy setting.

[0056] In the following some exemplary pre-configured programs (so-called program consult programs) are listed below that can be proposed to the user of the programming device 2 upon indicating that the His bundle electrode 4 is connected to the port 3 of the pacemaker 1.

[0057] Depending on the patient condition and the type of implant a configuration for the placement of the electrodes is proposed to the user. The following table list some examples of pre-configured programs to support adequate programming of His bundle pacing for different device types: SR (single chamber device), DR (dual chamber device), and HF (triple chamber device); Atrial Fibrillation (AF); Atrio-ventricular (AV); Left-Ventricular (LV); Right-Ventricular (RV); Coronary-Sinus (CS).

TABLE-US-00001 Device Configuration: port >> Type Program chamber/placement SR Bradycardia with permanent AF RVport >> HIS placement and His placement DR Permanent high-degree AV block RAport >> RA placement | with His placement plugged RVport >> HIS placement HF Heart failure, normal sinus, RAport >> RA placement | RV His placement, LV in RV plugged RVport >> HIS placement LVport >> RV placement (backup) HF Heart failure, normal sinus, RAport >> RA placement | RV His placement, LV in CS plugged RVport >> HIS placement LVport >> CS placement (backup)

[0058] The pre-configured programs could propose different pulse widths for the stimulation pulses (for example, a pulse width of 1 millisecond if the His bundle is stimulated), a different detection or sensing threshold, and/or an amplification gain, a rate-dependent atrio-hisian (AH) delay (for example, an AH1 delay after Pace of 70 milliseconds at a rate of 60 beats per minute) and/or a hisian-ventricular (HV) delay (for example, a HV delay after Pace of 30 milliseconds), for example, if the His bundle is stimulated for patients with normal sinus rhythm, equipped with a conventional triple chamber device and the His bundle pacing lead connected to the RV port of the device, and where the LV lead is placed in the coronary sinus.

[0059] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.